510(k) · Cleared
ClearedAtricure Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · FTD Lamp, Surgical
Cleared on Jul 1, 2004 as substantially equivalent to K961122 (Stryker Instruments, 1996) after a 10-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961122 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961122 Stryker KnifelightStryker Instruments · 1996
- This deviceK041681 Atricure DissectorAtriCure, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK111020 Atricure DissectorAtriCure, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
- Descendant · 2 generations on · 0 of its ownK232153 AvéliRevelle Aesthetics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK133425 Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight…Engineered Medical Solutions Co., LLC · 2013
- Descendant · cites it directly · 0 of its ownK062727 Cardioblate Navigator Tissue Dissection DeviceMedtronic Vascular · 2006
Most influential descendants
Showing 5 of 5 · See all- K111020Atricure DissectorAtriCure, Inc. · 2011 · cites it directly1descendant
- K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007 · cites it directly1descendant
- K232153AvéliRevelle Aesthetics, Inc. · 2023 · 2 generations on0descendants
- K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013 · 2 generations on0descendants
- K062727Cardioblate Navigator Tissue Dissection DeviceMedtronic Vascular · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961122 | Stryker Knifelight | Stryker Instruments | 1996 | — |
| 0 (this device) | K041681 | Atricure Dissector | AtriCure, Inc. | 2004 | — |
| +1 | K111020 | Atricure Dissector | AtriCure, Inc. | 2011 | — |
| +1 | K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007 | — |
| +2 | K232153 | Avéli | Revelle Aesthetics, Inc. | 2023 | — |
| +2 | K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip… | Engineered Medical Solutions Co., LLC | 2013 | — |
| +1 | K062727 | Cardioblate Navigator Tissue Dissection Device | Medtronic Vascular | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961122 | Stryker KnifelightSummary page 1…ssectorM T is the Stryker Knifelight Lighted Knife (K961122). The Stryker Knifelight Lighted Knife is classified as a Dissector, Surgical, General and Plastic Surgery, per 21C… | 1996 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041681: Atricure Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041681
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026